BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 2003379 · Received March 1, 2011

    Report

    Report Number
    1423500-2011-02571
    Event Type
    Malfunction
    Date Received
    March 1, 2011
    Date of Event
    February 3, 2011
    Report Date
    February 3, 2011
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    FKX
    PMA / PMN Number
    K923065
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) - A BATCH REVIEW WAS PERFORMED ON POTENTIALLY ASSOCIATED LOT #H10J30039 WITH NO ISSUES NOTED. RECEIVED ONE ACTUAL SAMPLE IN REFERENCE TO THIS ALARM. DEVICE WAS VISUALLY INSPECTED WITH SOLUTION NOTED IN SET AND PLACED ON THE MACHINE FOR PRIMING. NO ALARMS NOTED, THE COMPLAINT COULD NOT BE CONFIRMED. THE ROOT CAUSE WAS UNDETERMINED. BAXTER WILL CONTINUE TO MONITOR SIMILAR REPORTS TO DETERMINE IF FURTHER ACTIONS ARE REQUIRED.

    Additional Manufacturer Narrative · 1

    (B)(4) - CORRECTED INFORMATION: SIMILAR REPORTS HAVE BEEN RECEIVED FOR THE REPORTED PROBLEM. THE ROOT CAUSE INVESTIGATION IS IN PROGRESS THROUGH (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). THE SAMPLE WAS DISCARDED BUT A COMPANION SAMPLE WAS AVAILABLE AND REQUESTED, BUT HAS NOT YET BEEN RECEIVED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, AND/OR UPON CONCLUSION OF BAXTER'S INVESTIGATION, A FOLLOW-UP MEDWATCH REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    ON (B)(6) 2011, THE HOME PATIENT (HP) CONTACTED BAXTER'S TECHNICAL SERVICE CENTER REGARDING A SYSTEM ERROR 2240 ALARM, WHICH OCCURRED ON THE HOME CHOICE (HC) DURING USE DURING FILL WHILE THE PATIENT WAS CONNECTED. BAXTER ADVISED THE HP TO DISCARD SUPPLIES AND EITHER FINISH THERAPY WITH A MANUAL EXCHANGE, OR START OVER WITH NEW SUPPLIES. BAXTER CONTACTED THE HP ON (B)(4) 2011 WHO STATED THAT SHE NOTICED NOTHING UNUSUAL WITH THE SUPPLIES, AND THAT SHE HAD COMPLETED THERAPY THE NIGHT OF THE INCIDENT WITH MANUALS. THE HP HAD A DIALYSIS CLINIC APPOINTMENT ON (B)(6) 2011 JUST AFTER THE SYSTEM 2240 ALARM INCIDENT, AND THE PDRN REPORTS THAT THE HP IS OK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HOMECHOICE AUTOMATED PD SET WITH CASSETTE SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - MOUNTAIN HOME H10J30039

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR HOME CHOICE CYCLER| DIANEAL LOW CA (B)(4) 5L/5L